Overview

To Assess the Impact of Ferric Carboxymaltose Compared With Iron Sucrose in Chinese Subjects on Correcting Iron Deficiency Anaemia

Status:
Completed

Trial end date:
2019-02-25

Target enrollment:

Participant gender:

Summary

The primary objective is to demonstrate the efficacy of ferric carboxymaltose (FCM) given in a simple dosing regimen in correcting iron deficiency anaemia (IDA), by demonstrating non-inferiority to treatment with the currently approved intravenous (IV) iron therapy of iron sucrose (IS, Venofer™) in the Chinese population. The secondary objectives are to assess the safety of FCM compared to IS in the Chinese population and to evaluate the effect of FCM compared to IS on relevant laboratory parameters (haematology, chemistry, iron parameters) in the Chinese population.

Phase:

Phase 3

Details

Lead Sponsor:

Vifor (International) Inc.
Vifor Inc.

Collaborator:

Tigermed Consulting Co., Ltd

Treatments:

Ferric Compounds
Ferric Oxide, Saccharated
Iron